MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS STEM EXTENSION; PROSTHESIS, KNEE

Model Number	KSP20100E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record and sterilization batch release record were reviewed and indicated that the component involved met specification.The component was unable to be obtained for further analysis.Post-operative x-rays were provided of the femur which confirmed that the patient had a non-union fracture, above the tip of the stem, and that a plate and cables were placed to stabilize the bone.Should additional information be obtained the report will be supplemented.
Event or Problem Description
The patient underwent a revision surgery due to a non-union femoral fracture above the end of the stem within the intramedullary canal.

• Brand Name: ELEOS STEM EXTENSION
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 9356065
• Report Number: 3013450937-2019-00068
• Device Sequence Number: 469778
• Product Code: KRO
• UDI-Device Identifier: B278KSP20100E0
• UDI-Public: B278KSP20100E0
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/21/2025
• Device Model Number: KSP20100E
• Device Catalogue Number: KSP20100E
• Device Lot Number: 1696598
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 11/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR